The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.
The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome. Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
465
IU Health Arnett Medical Weight Loss
West Lafayette, Indiana, United States
Change from Baseline Type-2 Diabetes Status
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Metabolic Syndrome Status
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: * Waist circumference: ≥40 inches (men) or ≥35 inches (women) * Fasting triglycerides: ≥150 mg/dL * HDL-C: \<40 mg/dL (men) or \<50 mg/dL (women) * Blood pressure: ≥130/85 mm Hg or use of hypertensive medication * Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Body Weight
Body weight will be evaluated on a calibrated scale
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Carotid Intima Media Thickness (CIMT) (intervention and usual care arms, participants with type 2 diabetes only)
Ultrasound Measurement of the Carotid Artery
Time frame: 12 and 24 Months
Change from Baseline Serum Lipids
Serum lipids including lipoprotein size and number
Time frame: 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)
Change from Baseline Body Composition
Body composition will be determined using dual-energy X-ray absorptiometry (DXA), which provides accurate information on total body and regional fat, lean body mass, and bone mass
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Time frame: 3,12 and 24 Months (intervention arms only)
Change from Baseline Type-2 Diabetes Status
Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c)
Time frame: 42 and 60 Months (intervention arms only)
Change from Baseline Metabolic Syndrome Status
Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following: * Waist circumference: ≥40 inches (men) or ≥35 inches (women) * Fasting triglycerides: ≥150 mg/dL * HDL-C: \<40 mg/dL (men) or \<50 mg/dL (women) * Blood pressure: ≥130/85 mm Hg or use of hypertensive medication * Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication
Time frame: 42 and 60 Months (intervention arms only)
Change from Baseline Body Weight
Body weight will be evaluated on a calibrated scale
Time frame: 42 and 60 Months (intervention arms only)